Browsing Tag
accelerated approval
3 posts
Could nomlabofusp become the rare disease catalyst that revalues Larimar?
Larimar’s rolling BLA and nomlabofusp data sharpen LRMR’s rare disease biotech story around Friedreich’s ataxia, frataxin and accelerated approval.
uniQure moves closer to FDA approval as AMT-130 gene therapy shows progress for Huntington’s disease
Find out how uniQure’s AMT-130 regulatory path for Huntington’s disease is evolving after the FDA’s latest feedback on its data sufficiency.
Breakthrough trial: Oncolytics Biotech’s pelareorep combo doubles response rate in advanced anal cancer
Find out how Oncolytics Biotech’s breakthrough trial doubled response rates in advanced anal cancer and set up a 2026 FDA path.